A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting

Summary

This is a phase II, prospective, randomized, double-blind, placebo-controlled, international (Spain and Sweden) and multicentre study to explore the safety of 0.005% estriol vaginal gel in women with early stage breast cancer in treatment with Non-Steroidal Aromatase Inhibitors (NSAIs) in the adjuvant setting and symptoms of vaginal atrophy.

Timeline

Start

2015-10-16

Primary completion

2017-02-10

Completion

2017-02-10

Publications

• Sanchez-Rovira P, Hirschberg AL, Gil-Gil M, Bermejo-De Las Heras B, Nieto-Magro C. A Phase II Prospective, Randomized, Double-Blind, Placebo-Controlled and Multicenter Clinical Trial to Assess the Safety of 0.005% Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women with Early Stage Breast Cancer in Treatment with Aromatase Inhibitor in the Adjuvant Setting. Oncologist. 2020 Dec;25(12):e1846-1854. doi: 10.1634/theoncologist.2020-0417. Epub 2020 Jun 9.

Drugs

Indications